Protocol summary

Study aim
Response of eight weeks of selected Pilates training on lipid profile, fasting blood sugar, blood pressure and fat percentage of women with non-alcoholic fatty liver disease in Ahvaz city
Design
In this semi-experimental study, 20 women with non-alcoholic fatty liver disease (NAFLD) were selected in two groups with equal numbers by simple randomization method.
Settings and conduct
The present study was a semi-experimental and applied research. To conduct the study, 20 volunteer women with non-alcoholic fatty liver disease were selected at the Fibroscan Department of Aria Hospital. The subjects were divided into the Pilates training (N=10) and control (N=10) groups by simple randomization method. Blood pressure and fat percentage were measured before and after the end of eight weeks of intervention. 24 hours before the start of the protocol, the subjects attended the laboratory at 9:00 a.m. following 12 hours of fasting and their blood samples were taken by the laboratory technician for measuring FBS, TG, TC, HDL, LDL, VLDL levels. At the end of eight weeks and 48 hours after the end of the protocol, the blood test was taken again
Participants/Inclusion and exclusion criteria
Women with non-alcoholic fatty liver disease, age range from 30 to 55 years, not suffering from cardiovascular, joint and skeletal diseases, not performing regular sports activities during the last 6 months/ Taking supplements or lipid-lowering medication
Intervention groups
The first intervention group: Pilates group performed performed 60 minutes(10 min warm‑up, 40 min Pilates training, and 10 min cool‑down) of Pilates training three days a week for eight weeks in the gym. The second intervention group: The control group did not do any sports activities.
Main outcome variables
Improving performance activity, getting familiar with Pilates training and its effects, improving research information for the future

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230216057435N2
Registration date: 2023-12-23, 1402/10/02
Registration timing: retrospective

Last update: 2023-12-23, 1402/10/02
Update count: 0
Registration date
2023-12-23, 1402/10/02
Registrant information
Name
Sedigheh Kaabomeir
Name of organization / entity
The University of Shahid Chamran of Ahvaz
Country
Iran (Islamic Republic of)
Phone
+98 916 090 4022
Email address
s.kaabomeir1996@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-20, 1402/02/30
Expected recruitment end date
2023-07-22, 1402/04/31
Actual recruitment start date
2023-06-21, 1402/03/31
Actual recruitment end date
2023-08-23, 1402/06/01
Trial completion date
2023-10-23, 1402/08/01
Scientific title
Response of eight weeks of selected Pilates training on lipid profile, fasting blood sugar, blood pressure and fat percentage of women with non-alcoholic fatty liver disease in Ahvaz city
Public title
Selected Pilates training on lipid profile, fasting blood sugar, blood pressure and fat percentage of women with non-alcoholic fatty liver disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Women with non-alcoholic fatty liver disease Age range from 30 to 55 years Not suffering from cardiovascular, joint and skeletal diseases Not performing regular sports activities during the last 6 months
Exclusion criteria:
Taking supplements or lipid-lowering medication
Age
From 30 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
Actual sample size reached: 20
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the lottery method of simple random sampling was used. To this end, the samples were numbered from 1 to 20 without observing the order and a number was assigned to each one. Then, without respecting the order written on similar cards from 1 to 20, the cards were shuffled and placed in the lottery box. Each participant chose a random card so that eventually the cards with even numbers comprised the Pilates group and the cards with odd numbers comprised the control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Sport Sciences Research Institute (SSRI)
Street address
Floor 5, Block B3, Oil Co. 2000 Unit Houses, Resalat District, Ahvaz, Khuzestan, IRAN
City
Ahvaz
Province
Khouzestan
Postal code
6177882869
Approval date
2023-06-20, 1402/03/30
Ethics committee reference number
IR.SSRC.REC.1402.067

Health conditions studied

1

Description of health condition studied
Non-alcoholic fatty liver disease
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified. (Nonalcoholic fatty liver disease [NAFLD])

Primary outcomes

1

Description
Lipid profile
Timepoint
24hours before and 48 hours after the end of the protocol
Method of measurement
Laboratory test kits

2

Description
Fasting blood sugar
Timepoint
24hours before and 48 hours after the end of the protocol
Method of measurement
Laboratory test kits

3

Description
Blood pressure
Timepoint
24hours before and 48 hours after the end of the protocol
Method of measurement
Automatic Blood Pressure

4

Description
Fat percentage
Timepoint
24hours before and 48 hours after the end of the protocol
Method of measurement
Harpenden calipers

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Pilates group performed performed 60 minutes(10 min warm‑up, 40 min Pilates training, and 10 min cool‑down) of Mat Pilates training three days a week for eight weeks in the gym. They did it without equipment using their body weight in the presence of a Pilates coach.
Category
Lifestyle

2

Description
Control group: did not do any sports activities.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Aria Hospital in Ahvaz
Full name of responsible person
Abdolhamid Habibi
Street address
Golestan Blvd, Shahid chamran University of Ahvaz, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6135783151
Phone
+98 916 118 4888
Email
hamidhabibi330@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Chamran University of Ahvaz
Full name of responsible person
Abdolhamid Habibi
Street address
Golestan Blvd, Shahid Chamran University of Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135783151
Phone
+98 916 118 4888
Email
hamidhabibi330@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Chamran University of Ahvaz
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Chamran University of Ahvaz
Full name of responsible person
Sedigheh Kaabomeir
Position
Master of Sports Physiology
Latest degree
Master
Other areas of specialty/work
Sports Physiology
Street address
Floor 5, Block B3, Oil Co. 2000 Unit Houses, Resalat District, Ahvaz, Khuzestan
City
Ahvaz
Province
Khouzestan
Postal code
6177882869
Phone
+98 916 090 4022
Email
s.kaabomeir1996@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Chamran University of Ahvaz
Full name of responsible person
Sedigheh Kaabomeir
Position
Master of Sports Physiology
Latest degree
Master
Other areas of specialty/work
Sports Physiology
Street address
Floor 5, Block B3, Oil Co. 2000 Unit Houses, Resalat District, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6177882869
Phone
+98 916 090 4022
Email
s.kaabomeir1996@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Chamran University of Ahvaz
Full name of responsible person
Sedigheh Kaabomeir
Position
Master of Sports Physiology
Latest degree
Master
Other areas of specialty/work
Sports Physiology
Street address
Floor 5, Block B3, Oil Co. 2000 Unit Houses, Resalat District, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6177882869
Phone
+98 916 090 4022
Email
s.kaabomeir1996@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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